A F-I-H Study to Investigate QCC374 in Healthy Subjects
Research type
Research Study
Full title
A randomized, double-blind, placebo-controlled first-in-human study to assess the safety, tolerability and pharmacokinetics of single and multiple ascending doses of inhaled QCC374 in healthy subjects
IRAS ID
156014
Contact name
Girish Sharma
Contact email
Sponsor organisation
Novartis Institutes for BioMedical Research, Inc.
Eudract number
2013-004608-20
Research summary
This study is looking at a drug called QCC374 which is a novel inhaled drug designed as a therapy for Pulmonary Arterial Hypertension (PAH). The purpose of this study is to look at the safety, tolerability and pharmacokinetics (of single and multiple ascending doses of QCC374 in healthy subjects.
QCC374 is an inhaled compound formulated for dry powder inhalation and is a selective agonist for the prostacyclin receptor. Because QCC374 is designed for inhalation, it is expected to have improved safety, tolerability and ease of use compared to other similar drugs
The population eligible to take part in the study includes healthy male and female subjects age 18 to 55 years, in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests completed during screening at Simbec.
The study will be conducted in two parts. Part 1 is a randomized, double-blind, placebo-controlled, multiple-cohort ascending single dose study to assess single dose safety, tolerability and pharmacokinetics.
Part 1 will take place as 7 dose cohorts, each enrolling 8 subjects; 6 will be randomized to receive QCC374 and 2 to receive a matching placebo. The treatment period will consist of five days (day before dosing (Day -1) to Day 4).
Part 2 is a randomized, double-blind, placebo-controlled, multiple ascending dose study to assess safety, tolerability and pharmacokinetics in healthy subjects. The Part 2 study will comprise of 3 dose cohorts, each enrolling 12 subjects; 8 subjects will be randomized to receive the active study drug QCC374 and 4 subjects to receive the matching placebo. The treatment schedule is twice daily for 10 days and each part of the study will consist of a 4 week screening period, a treatment period and an end of study visit 4 weeks after the last dose.
REC name
Wales REC 1
REC reference
14/WA/0173
Date of REC Opinion
1 Jul 2014
REC opinion
Further Information Favourable Opinion